Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03068234
Eligibility Criteria:
Inclusion Criteria:
* Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).
* Subjects must have mRSS≥10 at screening stage
* Subjects must have signs of fibrosis in their chest CT at screening stage
* If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)
Exclusion Criteria:
* Subjects with other connective tissue diseases overlapping with SSc
* Subjects with skin atrophy as the main cutaneous manifestation
* Subjects with active digital ulcers or gangrene
* Active severe SSc-driven renal disease or heart dysfunction at screening
* Subjects with significant hematologic abnormalities
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* Active tuberculosis
* Live or attenuated vaccine within 4 weeks prior to screening
* Subjects with significant hematologic abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03068234
Study Brief:
Protocol Section:
NCT03068234